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Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).   Recruitment status was  Recruiting

First Received on December 14, 2005.   Last Updated on July 7, 2009   History of Changes
Sponsor: University of Chicago
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00265798
  Purpose

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with malignant gastrointestinal stromal tumor that progressed during or after previous treatment with imatinib mesylate and sunitinib malate.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Drug: sorafenib tosylate
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of BAY 43-9006 for Imatinib- and Sunitinib-Resistant Malignant Gastrointestinal Stromal Tumor

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate (partial and complete response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: September 2005
Estimated Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate (partial and complete response) in patients with imatinib mesylate- and sunitinib malate-resistant malignant gastrointestinal stromal tumor treated with sorafenib.

Secondary

  • Determine the toxicity of this drug in these patients.
  • Determine the progression-free survival and overall survival of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with imatinib mesylate and sunitinib malate (imatinib mesylate- and sunitinib malate-responsive disease vs primary imatinib mesylate- and sunitinib malate-refractory disease).

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed gastrointestinal stromal tumor

    • Not amenable to curative surgery
  • Kit-expressing tumor
  • Disease progression (i.e., new lesion or 20% increase in unidimensional tumor size) on or after treatment with imatinib mesylate and sunitinib malate
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan

    • Only site of measurable disease must be outside of previously irradiated area
  • No known brain metastases

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT < 2.5 times upper limit of normal

Renal

  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance > 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled hypertension

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No evidence of bowel perforation or obstruction

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior angiogenesis inhibitors
  • No immunotherapy after the last dose of imatinib mesylate or sunitinib malate

Chemotherapy

  • No chemotherapy or chemoembolization therapy after the last dose of imatinib mesylate or sunitinib malate

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered

Other

  • At least 14 days since prior imatinib mesylate or sunitinib malate
  • No prior sorafenib
  • No prior inhibitors of MAPK-signaling intermediates
  • No other investigational agent after the last dose of imatinib mesylate or sunitinib malate
  • Concurrent anticoagulation therapy with warfarin allowed provided the following criteria are met:

    • On a therapeutic stable warfarin dose
    • INR ≤3
    • No active bleeding or pathologic condition that confers a high risk of bleeding
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent administration of any of the following:

    • Enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital)
    • Hypericum perforatum (St. John's wort)
    • Rifampin
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265798

Locations
United States, Illinois
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Hedy L. Kindler, MD University of Chicago
  More Information

Additional Information:
Publications:
Nimeiri HS, Maki RG, Kasza K, et al.: Activity of sorafenib (SOR) in patients (pts) with imatinib (IM) and sunitinib (SU)-resistant (RES) gastrointestinal tumors (GIST): a phase II trial of the University of Chicago Phase II Consortium. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-7, 2008.

Responsible Party: Everett E. Vokes, University of Chicago Cancer Research Center
ClinicalTrials.gov Identifier: NCT00265798     History of Changes
Other Study ID Numbers: CDR0000453540, UCCRC-13780A, NCI-7028
Study First Received: December 14, 2005
Last Updated: July 7, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
gastrointestinal stromal tumor

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Sorafenib
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 13, 2012